The Centre for Tissue Engineering became the first tissue bank in South Africa to obtain an international ISO 13485 as well as the ISO 9001:2000 accreditation. This standard specifies requirements for a quality management system where an organisation needs to demonstrate its ability to provide consistent, safe, high-standard and quality bone tissue allografts to the medical fraternity.
The International Organisation for Standardisation, widely known as ISO is an international-standard-setting body composed of representatives from various national standards organisations. Compliance with ISO 13485 is often seen as the first step in achieving conformity with European regulatory requirements.
ISO 13485 contains requirements that are essential for any organisation operating at any tier in the medical device and pharmaceutical supply chain. It is especially relevant to manufacturers that wish to demonstrate applicable regulatory requirements, and by organisations whose services support medical device manufacturers. The standard contains specific requirements for manufacture, installation and servicing and calls for the implementation of a Quality Management System with several enhancements, risk Management approach to product development and product realisation, validation of processes, compliance with statutory and regulatory requirements and effective product traceability and recall systems amongst others.